Transition to Ambulatory Bariatric Surgery (TABS) Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Same Day Discharge.
- Who it may be relevant to
- Registry conditions: Obesity and Obesity-related Medical Conditions, Bariatric Surgery. Basic parameters: 25 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
This study will compare same day discharge and at least one night stay in the hospital after bariatric surgery. Patients undergoing bariatric surgery will be randomized (i.e. have an equal chance of either plan) to either group. The study's primary outcome is the frequency patients in the study require a visit to the emergency room within 7 days of their surgery.
Detailed description
This pragmatic, parallel, randomized, open-label trial aims to determine the safety and feasibility of same day discharge (SDD) for bariatric surgery including sleeve gastrectomy and gastric bypass. Investigators will investigate the frequency of 7-day emergency department visits with SDD after bariatric surgery (Aim 1). In addition, the investigators will compare total 30-day charges between participants who undergo same day discharge versus those receive post-operative hospital admission (Aim 2).
Interventions
- Other Same Day Discharge
Patients in the same day discharge arm will be discharged from the hospital within 6 hours of arriving to the recovery unit and without an overnight stay in the hospital.
Primary outcome measures
- Emergency Department Visits [Time frame: baseline to seven days]
Secondary outcome measures (2)
- Readmissions to the hospital [Time frame: baseline to 30 days]
- The number of operations or procedures [Time frame: baseline to 30 days]
Eligibility criteria
Inclusion criteria
- BMI ≤ 60 kg/m2
- Primary Sleeve gastrectomy or Gastric Bypass,
- Undergoing bariatric surgery at sponsor site
Exclusion criteria
- Type 1 Diabetes
- Myocardial Infarction
- Unstable Angina or Heart Failure
- Prior Stroke
- Solid organ transplantation
- Systemic glucocorticoid prior 28 days
- Severe Obstructive Sleep Apnea
- Uncontrolled Hypertension (Systolic > 150, Diastolic > 90)
- Untreated Hyperthyroidism
- Chronic Kidney Disease (EGFR < 60)
- Current anticoagulant use,
- Poorly controlled Type 2 diabetes (Hemoglobin A1c in last 3 months > 8.5%)
- Chronic opioid use
- Insulin dependence.
- Need for extended venous thromboembolic event prophylaxis,
- > 1 lifetime bariatric surgery (revisional or conversion bariatric surgery)
- Patient lives > 130 miles from the hospital.
- Tobacco use in last 12 months
- Desire to become pregnant or active pregnancy
- Prisoners
- Unable or unwilling to follow-up
- Unable to understand or provide consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Vanderbilt University Medical Center — Nashville
Identifiers
NCT: NCT07011628 · 250548